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Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

NCT ID: NCT05161676

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2023-10-01

Brief Summary

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Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and \>50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.

Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketone monoester (3-OHB)

Group Type EXPERIMENTAL

Ketone monoester

Intervention Type DIETARY_SUPPLEMENT

Commercially available ketone supplement

Placebo Treatment

Group Type EXPERIMENTAL

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Isocaloric placebo

Interventions

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Ketone monoester

Commercially available ketone supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

Isocaloric placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Chronic heart failure with NYHA II-III
* Left ventricular ejection fraction ≤40%
* Negative urine-HCG for women with childbearing potential

Exclusion Criteria

* Known diabetes or HbA1c ≥48 mmol/mol
* Significant cardiac valve disease
* Severe stable angina pectoris
* Age \<18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Kristoffer Berg-Hansen

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KETO-CHF Metabolic

Identifier Type: -

Identifier Source: org_study_id